MAUDE Report Exposes Alinity M System Flaws

May 4, 2023 · these are among the findings and conclusions of researchers who analyzed 266 u. s. Safety events reported to the fda’s manufacturer and user facility device experience. Oct 16, 2024 · the manufacturer and user facility device experience (maude) database is an online searchable database developed by the fda that houses reports of adverse outcomes. May 7, 2021 · the exponential growth of medical technology prompted the united states government to pass the safe medical devices act in 1990 requiring facilities to report adverse. Abbott is trying to convince us that once their sexual health panel is fda approved, we should switch to alinity m.

Internal studies concluded that the source of cycle number delay can be traced to metal leaching into the lysis solution from the lysis transfer pump in the alinity m system. impact on product. Real time nucleic acid amplification system. A complaint review was performed as part of (b)(4) risk associated with supplier notification for a software defect in the mechanical and thermal test system that can cause the amp detect. An analysis of maude data was performed to examine the outcomes and device characteristics of adverse event reports from 1991 up to 11/2022.